Behavioral Neurocardiac Training and Hypertension

This study has been completed.
Sponsor:
Collaborator:
Unilever R&D
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00811811
First received: December 18, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

This randomized controlled trial will examine whether behavioral neurocardiac training with heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation training), among subjects diagnosed with hypertension, and following adjustment for medications. In addition, the independent association between the BNT and AC interventions on vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a standardized assessment protocol of mental stress testing. This study extends a previous trial conducted at the UHN, in which we reported that the biofeedback intervention independently augments vagal-heart rate modulation, while reducing symptoms of stress and depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of this trial will examine the association between ambulatory blood pressure, vagal-heart rate modulation, baroreflex sensitivity, and markers of inflammatory activity.


Condition Intervention
Hypertension
Behavioral: Behavioral neurocardiac training
Behavioral: Autogenic relaxation training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure. [ Time Frame: Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral neurocardiac training
Behavioral: Behavioral neurocardiac training
6 training sessions scheduled over 8 weeks
Active Comparator: 2
Autogenic relaxation training
Behavioral: Autogenic relaxation training
6 training sessions scheduled over 8 weeks

  Eligibility

Ages Eligible for Study:   35 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 35 to 64 years of age
  • diagnosis of Grade 1 or 2 hypertension (140-159 mmHg or 160-180 mmHg SBP; or 90-99 or 100-110 mmHg DBP, respectively).
  • among subjects not prescribed medication, hypertension confirmed by ambulatory BP monitoring: mean 24-hour SBP > 130 mmHg or DBP > 80 mmHg.
  • subjects prescribed antihypertensive pharmacotherapy are required to have a treatment regimen that was unchanged for at least 4 months prior to enrollment.

Exclusion criteria:

  • diagnosis of cardiovascular disease, clinically significant arrhythmia, sleep disorder, psychiatric illness (eg. psychosis), alcohol/drug dependence within the previous year, or an inability to comprehend English or French
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811811

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Unilever R&D
Investigators
Principal Investigator: Robert P Nolan, Ph.D. University Health Network, Toronto
  More Information

No publications provided by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert P. Nolan/Director Behavioural Cardiology Research Unit, University Health Network
ClinicalTrials.gov Identifier: NCT00811811     History of Changes
Other Study ID Numbers: 04-516-BE
Study First Received: December 18, 2008
Last Updated: December 18, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Hypertension
Biofeedback
Relaxation training

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014